VIIBRYD SIDE EFFECTS
- Generic Name: vilazodone hydrochloride
- Brand Name: Viibryd
- Drug Class: How Do SSRI/5HT-1A Partial Agonist Antidepressants Work?
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Suicidal Thoughts and Behaviors in Adolescents and Young Adults
- Serotonin Syndrome
- Increased Risk of Bleeding
- Activation of Mania or Hypomania
- Discontinuation Syndrome
- Seizures
- Angle-Closure Glaucoma
- Hyponatremia
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions and varying lengths of time, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.
The most commonly observed adverse reactions in VIIBRYD-treated patients with major depressive disorder (MDD) in placebo-controlled studies (incidence ≥ 5% and at least twice the rate of placebo) were diarrhea, nausea, vomiting, and insomnia.
Patient Exposure
The safety of VIIBRYD was evaluated in 3,007 patients (18-70 years of age) diagnosed with MDD who participated in clinical studies, representing 676 patient-years of exposure. In an open-label 52 week study at 40 mg daily, 599 patients were exposed to VIIBRYD for a total of 348 patient-years.
The adverse reaction information presented below was derived from studies of VIIBRYD 20 mg and 40 mg daily in patients with MDD including:
- Four placebo-controlled 8 to 10-week studies in 2,233 patients, including 1,266 VIIBRYD-treated patients; and
- An open-label 52-week study of 599 VIIBRYD-treated patients.
These studies included a titration period of 10 mg daily for 7 days, followed by 20 mg daily for 7 days or to 40 mg daily over 2 weeks. In these clinical trials, VIIBRYD was administered with food.
Adverse Reactions Reported As Reasons For Discontinuation Of Treatment
In these studies, 7.3% of the VIIBRYD-treated patients discontinued treatment due to an adverse reaction, compared with 3.5% of placebo-treated patients. The most common adverse reaction leading to discontinuation in at least 1% of the VIIBRYD-treated patients in the placebo-controlled studies was nausea (1.4%).
Common Adverse Reactions In Placebo-Controlled MDD Studies
Table 1 shows the incidence of common adverse reactions occurring in ≥ 2% of VIIBRYD-treated patients and greater than the rate of placebo-treated patients in MDD Studies. There were no dose-related adverse reactions between 20 mg and 40 mg reported.
Table 1: Common Adverse Reactions Occurring in ≥ 2% of VIIBRYD-treated Patients and Greater than the Rate of Placebo-Treated Patients
| System Organ Class Preferred Term |
VIIBRYD 40 mg/day N=978 |
VIIBRYD 20 mg/day N=288 |
VIIBRYD 40 mg/day N=978 |
| Gastrointestinal disorders | |||
| Diarrhea | 10% | 26% | 29% |
| Nausea | 7% | 22% | 24% |
| Dry mouth | 5% | 8% | 7% |
| Vomiting | 2% | 4% | 5% |
| Abdominal pain1 | 3% | 7% | 4% |
| Dyspepsia | 2% | 2% | 3% |
| Flatulence | 1% | 3% | 3% |
| Gastroenteritis | 1% | 1% | 2% |
| Abdominal distension | 1% | 2% | 1% |
| Nervous system disorders | |||
| Headache2 | 14% | 15% | 14% |
| Dizziness | 5% | 6% | 8% |
| Somnolence | 2% | 4% | 5% |
| Paresthesia | 1% | 1% | 2% |
| Psychiatric disorders | |||
| Insomnia | 2% | 7% | 6% |
| Abnormal dreams | 2% | 2% | 3% |
| Restlessness3 | 1% | 2% | 3% |
| General disorders | |||
| Fatigue | 3% | 4% | 3% |
| Cardiac disorders | |||
| Palpitations | <1% | 1% | 2% |
| Metabolism and nutrition disorders | |||
| Increased appetite | 1% | 1% | 3% |
| Musculoskeletal and connective tissue disorders | |||
| Arthralgia | 1% | 2% | 1% |
| Investigations | |||
| Increased weight | 1% | 1% | 2% |
| 1 Includes abdominal discomfort, abdominal pain upper, and abdominal pain. 2 Includes headache and tension headache 3 Includes restlessness, akathisia, and restless legs syndrome |
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Sexual Adverse Reactions
Table 2 displays the most common sexual adverse reactions in the placebo-controlled MDD studies.
Table 2: Common Sexual Adverse Reactions Occurring in ≥ 2% of VIIBRYD-treated Patients and Greater than the Rate of Placebo-Treated Patients
| Preferred Term | Males | Females | ||||
| Placebo N=416 |
VIIBRYD 20 mg/day N=122 |
VIIBRYD 40 mg/day N=417 |
Placebo N=551 |
VIIBRYD 20 mg/day N=166 |
VIIBRYD 40 mg/day N=561 |
|
| Abnormal Orgasm* | <1% | 2% | 2% | 0% | 1% | 1% |
| Erectile dysfunction | 1% | 0% | 3% | – | – | – |
| Libido decreased | <1% | 3% | 4% | <1% | 2% | 2% |
| Ejaculation disorder | 0% | 1% | 2% | – | – | – |
| − Not applicable * Includes abnormal orgasm and anorgasmia |
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Other Adverse Reactions Observed In Clinical Studies
The following list does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.
Reactions are categorized by body system according to the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients:
Cardiac disorders: infrequent: ventricular extrasystoles
Eye disorders: infrequent: dry eye, vision blurred, rare: cataracts
Nervous System: frequent: sedation, tremor; infrequent: migraine
Psychiatric disorders: infrequent: panic attack
Skin and subcutaneous tissue disorders: infrequent: hyperhidrosis, night sweats
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of VIIBRYD. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure. Reports of adverse reactions temporally associated with VIIBRYD that have been received since market introduction and that are not listed above include the following:
General Disorders and Administration Site Conditions: irritability
Nervous System Disorders: sleep paralysis
Psychiatric Disorders: hallucinations, suicide attempt, suicidal ideation
Skin and subcutaneous tissue disorders: rash, generalized rash, urticaria, drug eruption
Gastrointestinal System: acute pancreatitis.
SRC: NLM .